S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in Hepatocellular Carcinoma (HCC). S-1 combined with calcium folinate (SL) showed very good efficiency and safety in colorectal cancer (CRC). The short duration (two weekly regimen) is better than common course 4 week regimen in tolerance. So the investigators want to examine the efficiency and safety of SL one week on and one week off regimen in HCC.

S-1 capsules 80mg/m2/d BID one week on and one week off Leucovorin tablets 50mg/d BID one week on and one week off

Other Names:

TS-1

formyltetrahydrofolate

Detailed Description:

S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in HCC. S-1 combined with calcium folinate (SL) showed very good efficiency and safety in CRC. The short duration (two weekly regimen) is better than common course 4 week regimen in tolerance. So the investigators want to examine the efficiency and safety of SL one week on and one week off regimen in HCC.

SL one week on and one week off regimen will be give to advanced HCC patients. The primary endpoint is durable complete response (DCR).

Eligibility

Ages Eligible for Study:

18 Years to 70 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female, 70 years > Age > 18 years

Patient with unresectable primary hepatocellular carcinoma

Child-Pugh Class A or B, without ascites

ECOG score 0

At least one tumor nodule can be evaluated by CT or MRI

Can take medicine orally

Expected survival time not less than 12 weeks

Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study During the trial and 4 week after the trial, must take contraception

Patients must be:

Hemoglobin > 9.0g/dl

ANC > 1.5×109/L

Platelet ≥ 60×109/L

Total bilirubin < 3mg/dl

ALT or AST < 5 X ULN

ALP < 4 X ULN

PT-INR < 2.3

Patients who is taking Warfarin , should be tested every week till getting stable INR

Serum creatinine < 1.5 X ULN

Serum amylase and lipase < 2 X ULN

Exclusion Criteria:

Known or suspected allergy to any agent given in association with this trial

Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.

Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics.

Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study

Patients unable to swallow oral medications.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533324